FDA Proposes Regulations for Genetically Engineered Animals

Lutter said the U.S. Food, Drug and Cosmetics Act gives the FDA the authority to regulate genetically engineered animals.

"Genetically engineered animals that contain a recombinant DNA segment that is intended to alter the structure or function of the animal are considered to contain a new animal drug," he said. "Genetically engineered animals will, therefore, require premarket approval by FDA prior to their introduction into the marketplace."

Dr. Larisa Rudenko, senior adviser for biotechnology at the FDA's Center for Veterinary Medicine, said the safety of genetically engineered animals intended for use as food will be decided on a case-by-case basis.

"Attention will be paid to particular risks posed by each line of animal, although the basic test will be the same for all animals," Rudenko said during the teleconference. "If the animal is intended to be used for food or feed, we will have to do a full evaluation of food and feed safety. We will also perform an environmental assessment."

Producers of these animals will have to provide proof demonstrating that the new genetic traits perform as claimed, Rudenko said. "We will also ask producers to provide a plan for how they will monitor these animals to ensure that the genetically engineered animals entering commerce in the future are equivalent to those we have approved," she said.

Consumers Union, the nonprofit publisher ofConsumer Reportsmagazine, said it was deeply troubled that the FDA said it would only review genetically engineered animals for their safety as food and would not require any labeling.

"It is incomprehensible to us that FDA does not view these animals as different from their conventional counterparts, and therefore something that under law is required to be labeled," Jean Halloran, director of food policy initiatives at Consumers Union, said in a news release. "In our view, consumers have a right to know if the ham, bacon or pork shops they are buying come from pigs that have been engineered with mouse genes."

Supporting that view was Jaydee Hanson, a policy analyst on cloning and genetics at the Center for Food Safety, who said the new guidelines don't go far enough. "It's bad, because the FDA does not require labeling of genetically engineered animal products. It's bad, because the process is entirely confidential," Hanson said.

The only labeling the FDA requires is related to health claims producers make about their genetically engineered products.

"It's bad because the new animal drug system is only intended to look at toxicity of chemicals in the human body. It's not really intended to look at the biology of a new gene introduced into every cell in animal," Hanson said.

Hanson thinks the consequences of not disclosing which foods are genetically modified is likely to cause more problems for the FDA. "This is an ideal way to have the public lose faith in the FDA -- they've already lost it and this doesn't rebuild it," he said.

More information

For more on genetically engineered animals visit the U.S. Food and Drug Administration.

SOURCES: Sept. 18, 2008, teleconference with Randall Lutter, Ph.D., deputy commissioner for policy, Office of the Commissioner, U.S. Food and Drug Administration; Larisa Rudenko, Ph.D., DABT, senior adviser for biotechnology, Center for Veterinary Medicine, FDA; Consumers Union, news release, Sept. 18, 2008; Jaydee Hanson, policy analyst on cloning and genetics, Center for Food Safety, Wash. D.C.